Compliance Inspection Report (Page 6 of 11) in pdf

Item

Requirements

YES

N/A

Comment / Observation

No.

Controlled Substances Records, con’t.

The date on which the controlled substances are actually received shall be used as the date of receipt (e.g., invoices or

packing slips). (247 CMR 9.01 (1)) (21 CFR 1304.21 (d))

Every registrant required to keep records pursuant to Sec.1304.03 shall maintain on a current basis a complete and

accurate record of each such substance disposed of by him/her (e.g., disposal/destruction records). (247 CMR 9.01 (1))

(21 CFR 1304.21 (a))

A registrant shall keep for at least two years from the date of preparation, every report, inventory and record he is

required to keep by 105 CMR 700.000. (247 CMR 9.01 (1)) (105 CMR 700.006 (b))

A pharmacist shall maintain prescription files as follows:

(1) Prescriptions for controlled substances in Schedule II shall be segregated from all other records and shall be

maintained in a separate file identified as such.

(2) Prescriptions for controlled substances in Schedules III, IV, and V shall be maintained in a separate file identified as

such.

(3) Prescriptions for controlled substances in Schedule VI, prescriptions for non-controlled substances, and prescriptions

for syringes and instruments adaptable to hypodermic administration, shall be segregated from all other records and

shall be maintained together in a separate file identified as such. (247 CMR 9.05 (1-3))

Authorization for Emergency Dispensing of Controlled Substances in Schedule II: Upon receipt of the written prescription

(with "Authorization for Emergency Dispensing" written on its face), the dispensing pharmacist shall attach the

prescription to the orally or electronically transmitted emergency prescription which had earlier been reduced to writing.

(247CMR 5.03(3) (4))

Procedures for transferring a prescription between pharmacies or pharmacy departments for prescriptions issued for

controlled substances in Schedules III, IV, and V are followed and performed by a pharmacist only. (247CMR 9.02 (2))

Procedures for transferring a prescription between pharmacies or pharmacy departments for prescriptions issued for

controlled substances in Schedule VI are followed and performed by a pharmacist or certified pharmacy technician only.

(247CMR 9.02 (3))

Subject to the provisions of federal regulations at 21 CFR 1306, an automated data-processing system may be used as

an alternative to the provisions of 247 CMR 9.04 (4) and (5). This data-processing system may be used for the storage

and retrieval of information pertaining to the refilling of prescriptions for controlled substances in Schedules III through VI

(e.g., daily reports or logs signed by pharmacist). (247 CMR 9.04 (6))

Equipment, Facility and Drug Storage

The equipment necessary to conduct the practice of pharmacy. (247 CMR 6.01 (5) (a) (5))

The premises of the pharmacy or pharmacy department shall at all times be kept in a clean and sanitary manner.

(247 CMR 6.02 (1))

A balance capable of accurately weighing quantities as small as 13 milligrams, which balance shall be tested and sealed

by the state or local sealer of weights and measures annually. (247 CMR 6.01 (5) (a) (4)) (247 CMR 9.01 (1)) NOTE: All

new equipment must meet the requirements in Massachusetts General Law: Ch. 98 Section 29.

Appropriate sanitary appliances, including a suitable sink which shall be equipped for hot and cold running water and

which shall be situated in or near the area in which prescriptions are to be filled. (247 CMR 6.01 (5) (a) (7))

While on duty, a pharmacist shall be responsible for the proper preservation and security of all drugs in the pharmacy or

pharmacy department, including the proper refrigeration and storage of said drugs. (247 CMR 9.01 (5))

Compliance Inspection Report Page 6

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